Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy
Vertex Pharmaceuticals Incorporated
1,100 participants
Oct 1, 2024
INTERVENTIONAL
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).
Eligibility
Inclusion Criteria4
- Body weight greater than or equal to (≥) 45 kilogram (kg)
- Body mass index (BMI) ≥18.0 to less than (<) 40.0 kilogram per meter square (kg/m\^2)
- Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
- Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period
Exclusion Criteria2
- More than 3 missing daily NPRS scores during the 7-day Baseline Period
- Any sensory abnormality (excluding DPN) as pre-specified in the protocol
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Interventions
Tablets for oral administration.
Placebo matched to SUZ for oral administration.
Capsules for oral administration.
Placebo matched to Pregabalin for oral administration.
Locations(76)
View Full Details on ClinicalTrials.gov
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NCT06628908